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FDA SAYS IVERMECTIN DOESN’T WORK AGAINST COVID-19 BUT POINTS TO STUDIES THAT
SHOW IT DOES

Covid News
Zachary Stieber
Follow
Dec 8 2022
biggersmaller
Ivermectin tablets packaged for human use. (Natasha Holt/The Epoch Times)
0:0023:25

1



The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does
not work against COVID-19 but links to studies that show it does, an Epoch Times
review has found.



The FDA’s website states, “Currently available data do not show ivermectin is
effective against COVID-19.”

But half of the studies to which the FDA points support using ivermectin against
COVID-19, according to the review.

The papers cut against the drug agency’s repeated exhortations for people not to
take ivermectin for COVID-19. In Twitter posts, public statements, and emails,
FDA officials have repeatedly warned against ivermectin. Some of those
statements triggered a lawsuit from doctors who say the agency’s role is to
approve drugs, not to issue recommendations. The suit was dismissed this week.

Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and
co-authored a meta-analysis that concluded the drug is effective against the
illness, told The Epoch Times that the government’s position on ivermectin “is
one of the most glaring examples of the corruption of modern evidence based
medicine.”

“There’s one message they want everyone to understand. And that message is that
ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s
theirs. That’s their perverted and distorted interpretation of the data.”

The FDA’s media office did not respond to a request for comment.

Dr. Janet Woodcock, a top official at the agency who was its commissioner from
January 2021 to February 2022, told The Epoch Times via email that “ivermectin
has been shown to be ineffective against COVID in large randomized trials.”

A sign for the Food And Drug Administration outside its headquarters in White
Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)


STUDIES

The FDA’s website points to a U.S. National Library of Medicine database of
studies analyzing ivermectin against COVID-19. There are 88 studies listed in
the database.

Out of studies that are listed, have been completed, and have results reported,
most show or indicate ivermectin effectively combats or prevents COVID-19,
according to the review by The Epoch Times.

They include papers reporting on results from randomized, controlled trials,
which are often offered as the highest level of evidence by U.S. government
officials. Such trials feature a group that receives a placebo and a group that
receives the drug, randomization into groups, and blinding, or shielding
operators and/or patients from the knowledge of which participants are receiving
ivermectin.

Among the papers is a randomized, blinded, controlled trial that found people
who received ivermectin and doxycycline, an antibiotic, recovered faster from
COVID-19 than those who received a placebo.

Bangladeshi researchers reported the results from the trial of 363 participants
on May 13, 2021, in the Journal of International Medical Research.

“Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus
doxycycline recovered earlier, were less likely to progress to more serious
disease, and were more likely to be COVID-19 negative by RT-PCR on day 14,” they
said. PCR has been used to test for COVID-19.

Another paper, published on July 7, 2022, in the International Journal of
Infectious Diseases, found that that ivermectin decreased the level of COVID-19
and its viability. Israeli researchers in the randomized, controlled, open label
trial compared 47 patients who received ivermectin against 42 who received
placebos and said that “ivermectin significantly reduced the time of viral
shedding and affected viral viability when initiated in the first week after
evidence of infection.”

“There were lower viral loads and less viable cultures in the ivermectin group,
which shows its anti-SARS-CoV-2 activity,” the researchers said. SARS-CoV-2 is a
name for the virus that causes COVID-19.

A third paper concluded that a regimen of ivermectin and carrageenan works as a
prophylaxis, or preventative medicine. Argentinian researchers found in
the observational trial involving 229 health care workers that ivermectin helped
prevent COVID-19 infection. A followup study involving nearly 1,200 workers
confirmed the results. Both sets were reported in the Journal of Clinical and
Biomedical Investigation on Nov. 17, 2020.

Ivermectin “could have saved so many lives,” Héctor Carvallo, one of the
researchers, told The Epoch Times via email, adding that “it’s been a crime
against mankind to prevent its prescription.”

Some other studies, including the largest ones, either found indications that
ivermectin works against COVID-19 but did not achieve statistical significance
or found no evidence that ivermectin is effective.

That includes a randomized, controlled, double-blind 2021 study by Mexican
researchers that found ivermectin did not significantly impact hospitalization
duration or mortality, and a randomized, controlled, double-blind 2022 trial by
U.S. researchers that concluded ivermectin did not prevent hypoxemia,
hospitalization, or death.










FDA INTERVENTION

Scientists in Australia in April 2020 found that ivermectin worked well against
the COVID-19 virus in cell culture, prompting doctors in multiple countries,
including Peru and the United States, to start using it against the new illness.

Ivermectin is approved by the FDA to treat parasites. One version is used on
horses and other animals.

The FDA quickly warned against using the animal form and said that people should
“not take any form of ivermectin unless it has been prescribed to them by a
licensed health care provider and is obtained through a legitimate source.”

Studies later in the year suggested ivermectin worked well in humans who had
COVID-19, including halting the progression of disease (pdf), helping patients
improve faster, and preventing COVID-19 infection, though other studies returned
results that did not support ivermectin as a treatment.

The FDA maintained its stance against COVID-19, and created a new web page on
March 5, 2021. It initially said, “The FDA has not reviewed data to support use
of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however,
some initial research is underway.”

In August 2021, the FDA urged people against using ivermectin by telling them
that “you are not a horse.” It linked to the page, which was updated the
following month with the language it now contains about data not showing
ivermectin is effective.

American doctors are allowed to prescribe drugs approved for one use for a
different use, a practice known as off-label. But doctors who prescribed
ivermectin soon found that many pharmacies stopped filling prescriptions, citing
advice from the FDA and other U.S. government bodies.

Studies on Ivermectin Against COVID-19 Date Journal Participants Outcome Effects
of Ivermectin-azithromycin-cholecalciferol combined therapy on COVID-19 infected
patients: A proof of concept study 2020 Biomedical Research 35 Positive
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management July 8,
2020 Preprint 87 Positive Safety and Efficacy of the Combined Use of Ivermectin,
Dexamethasone, Enoxaparin and Aspirin Against COVID-19 Sept. 15, 2020 Preprint
167 Positive Study of the Efficacy and Safety of Topical Ivermectin +
Iota-Carrageenan in the Prophylaxis against COVID-19 in Health Personnel Nov.
17, 2020 Journal of Biomedical Research and Clinical Investigation 229 Positive
Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A
Randomised Clinical Trial Feb. 1, 2021 Journal of Clinical and Diagnostic
Research 203 contacts to 52 index cases Positive Efficacy of Ivermectin in
COVID-19 Patients with Mild to Moderate Disease Feb. 5, 2021 Preprint 86
Positive A Comparative Study on Ivermectin-Doxycycline and
Hydroxychloroquine-Azithromycin Therapy on COVID-19 Patients Feb. 25, 2021
Eurasian Journal of Medicine and Oncology 116 Positive Ivermectin in combination
with doxycycline for treating COVID-19 symptoms: a randomized trial May 2021
International Journal of International Medical Research 363 Positive Effect of a
combination of nitazoxanide, ribavirin, and ivermectin plus zinc supplement
(MANS.NRIZ study) on the clearance of mild COVID‐19 May 2021 Journal of Medical
Virology 113 Positive Controlled Randomized Clinical Trial on Using Ivermectin
with Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq May 6, 2021
Iraqi Journal of Medical Sciences 140 Positive Clinical, Biochemical and
Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in
Reducing Upper Respiratory Symptoms of Mild COVID-19 June 15, 2021 International
Journal of Nanomedicine 114 Positive Ivermectin as a SARS-CoV-2 Pre-Exposure
Prophylaxis Method in Healthcare Workers: A Propensity Score-Matched
Retrospective Cohort Study Aug. 13, 2021 Cureus 271 Positive Intensive Treatment
With Ivermectin and Iota-Carrageenan as Pre-exposure Prophylaxis for COVID-19 in
Health Care Workers From Tucuman, Argentina Sept-Oct, 2021 American Journal of
Therapeutics 234 Positive Effectiveness of ivermectin-based multidrug therapy in
severely hypoxic, ambulatory COVID-19 patients Feb. 9, 2022 Future Microbiology
24 Positive Randomized trials – Ivermectin repurposing for COVID-19 treatment of
outpatients with mild disease in primary health care centers June 21, 2022
Research, Society and Development 254 Positive The effect of ivermectin on the
viral load and culture viability in early treatment of nonhospitalized patients
with mild COVID-19 – a double-blind, randomized placebo-controlled trial July 7,
2022 International Journal of Infectious Diseases 89 Positive The effect of
early treatment with ivermectin on viral load, symptoms and humoral response in
patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled,
randomized clinical trial Feb. 1, 2021 The Lancet 24 Mixed Positive impact of
oral hydroxychloroquine and povidone-iodine throat spray for COVID-19
prophylaxis: An open-label randomized trial April 2021 International Journal of
Infectious Diseases 3037 Mixed Clinical study evaluating the efficacy of
ivermectin in COVID-19 treatment: A randomized controlled study June 2, 2021
Journal of Medical Virology 164 Mixed Antiviral effect of high-dose ivermectin
in adults with COVID-19: A proof-of-concept randomized trial July 1, 2021 The
Lancet 45 Mixed Ivermectin compared with placebo in the clinical evolution of
Mexican patients with asymptomatic and mild COVID-19: a randomized clinical
trial May 23, 2022 Preprint 66 Mixed Efficacy and safety of ivermectin in the
treatment of mild to moderate COVID-19 infection: a randomized, double-blind,
placebo-controlled trial Aug. 26, 2022 Trials 72 Mixed Efficacy and Safety of
Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized
Controlled Trial Feb. 23, 2021 Infectious Disease Reports 106 Not Supportive
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild
COVID-19 March 4, 2021 Journal of American Medical Association 476 Not
Supportive Evaluation of the effectiveness and safety of adding ivermectin to
treatment in severe COVID-19 patients May 4, 2021 BMC Infectious Diseases 66 Not
Supportive Ivermectin to prevent hospitalizations in patients with COVID-19
(IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial July 2,
2021 BMC Infectious Diseases 501 Not Supportive Efficacy of Ivermectin Treatment
on Disease Progression Among Adults With Mild to Moderate COVID-19 and
Comorbidities Feb. 18, 2022 Journal of American Medical Association 490 Not
Supportive Effect of combined use of ivermectin and colchicine in COVID-19
patients June 22, 2022 Egyptian Journal of Anesthesia 135 Not Supportive
Pharmacometric assessment of the in vivo antiviral activity of ivermectin in
early symptomatic COVID-19 July 19, 2022 Preprint 96 Not Supportive Randomized
Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19 Aug. 18, 2022 New
England Journal of Medicine 1323 Not Supportive Ivermectin role in COVID-19
treatment (IRICT): single-center, adaptive, randomized, double-blind,
placebo-controlled, clinical trial Oct 20, 2022 Expert Review of Anti-infective
Therapy unclear Not Supportive Effect of Ivermectin vs Placebo on Time to
Sustained Recovery in Outpatients With Mild to Moderate COVID-19 Oct. 25, 2022
Journal of American Medical Association 1591 Not Supportive Note: Only studies
from the database linked to by the FDA that have been completed and have had
results released are included





HALF OF STUDIES SUPPORTIVE

The FDA does not cite studies on its website to support its statement that data
“do not show ivermectin is effective against COVID-19.”

“Clinical trials assessing ivermectin tablets for the prevention or treatment of
COVID-19 in people are ongoing,” the agency adds, providing a link to the U.S.
National Library of Medicine’s database.

Of the 88 studies listed there, 56 fall under one of three categories: have not
been completed, were completed but results have not been reported, or were
completed and have since been retracted or otherwise withdrawn.

Of the remaining 32, 16 found or indicate ivermectin is effective as a COVID-19
treatment or prophylactic, according to the Epoch Times review.

Two of the trials were randomized, controlled, and blinded. Nine others were
randomized and controlled but were not blinded at all. Most of the rest were
observational, meaning they analyzed data from real-world settings like
hospitals, or used observational data to create what’s known as a synthetic
control group.

The set of papers includes results of a randomized, controlled, open label
observational trial (pdf) that found ivermectin combined with doxycycline, an
antibiotic, reduced the time to recovery and the mortality rate, and a
randomized, controlled, double-blinded trial that found ivermectin and
doxycycline quickened recovery and patients were less likely to see their
disease progress.

Of the 16 other studies, six reported mixed results. For instance, Spanish
researchers reported in The Lancet in February 2021 that ivermectin did not have
an impact on testing results, but that there was “a marked reduction” of
self-reported symptoms such as loss of smell and cough, and lower levels of
viral loads. The result “warrants assessment in larger trials,” the researchers
said.

The remaining 10 studies returned results that did not favor ivermectin or did
not achieve statistical significance.

U.S. researchers, for example, found that ivermectin probably worked better than
a placebo, but that the results did not achieve statistical significance,
prompting them to say in October that “this study adds to the growing evidence
that there is not a clinically relevant treatment effect of ivermectin at this
dose and duration.”

The FDA did not respond to a request for comment on the revelation that half of
the studies it points to support using ivermectin (IVM) against COVID-19.

Woodcock, the FDA’s principal deputy commissioner, reviewed the studies. She was
unimpressed.

The Bangladeshi trial, for instance, was criticized for primarily including
young persons, and having a higher number of dropouts in the placebo arm.
Woodcock said the Israeli study did not report “clinical outcomes” and noted
many of the other papers had small numbers of participants.

“There are only a couple studies here that really look at the effects of IVM and
see a positive clinical effect and they are much smaller than the negative
studies,” Woodcock told The Epoch Times in an email.

The trials in favor of ivermectin are on the smaller side, and more likely to be
observational. But that doesn’t necessarily mean they are inferior, Kory said.
He cited research that found there was little difference between observational
studies and randomized-controlled trials, as well as a paper that said “study
design is only one factor that determines study quality.”

The FDA isn’t the only government group opposed to using ivermectin to treat
COVID-19. The National Institutes of Health (NIH) COVID-19 Treatment Guidelines
Panel recommends against it, citing several of the larger trials that found
little or no benefit for ivermectin. The panel cites none of the papers that
found a positive effect.

A health care worker holds a bottle of ivermectin in Colombia on July 21, 2020.
(Luis Robayo/AFP via Getty Images)


CRITICISM OF DESIGN

Many of those studies have been criticized over their design. One major factor,
critics say, is participants not receiving ivermectin soon after a positive test
or the start of symptoms.

In one trial, researchers acknowledged that more than 4 out of 10 participants
did not receive the dosage level that was listed as the “goal dose.” Further,
the median time from the start of symptoms to treatment was six days, and the
treatment duration was just three days. The trial, called ACTIV-6, was backed by
the NIH.

The corresponding author for the trial did not return a request for comment. The
authors said that “there was no evidence of a differential treatment effect
based on the median time of symptom onset to receipt of study drug.”

In another trial that reported little difference between the treatment and
control groups, the treatment group received ivermectin days after starting to
show symptoms.

Ivermectin works best when applied within 24 hours of symptom manifestation,
according to a meta regression of ivermectin studies performed by by an unnamed
group of researchers.

“They literally try to treat as late into the disease as they can, for a short
duration as they can, at the lowest dose that they can. And they also try to
find as healthy and mild patients as you can,” Kory said.

“And yet, when they conduct those kinds of trials, it’s on the front page of a
high-impact journal and the conclusion states, ‘this shows there’s no role for
ivermectin in treatments.’ Absolutely absurd. And so it’s it’s really just
corruption of these trials.”

Zachary Stieber
Reporter
Follow
Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He
covers U.S. and world news.



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